EGZ - BEUDAMED

i-STAT EG6+ cartridge. List Number: 03P77-25.

FDA Recall

Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall

Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

i-STAT EG7+ cartridge. List Number: 03P76-25.

FDA Recall

Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

i-STAT EG6+ cartridge; List Number: 03P77-25;

FDA Recall

Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

i-STAT G3+ cartridge; List Number: 03P78-26;

FDA Recall

Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

i-STAT EG7+ cartridge; List Number: 03P76-25;

FDA Recall

Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

i-STAT EG6+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.

FDA Recall

Terminated ·Abbott Point of Care Inc.·Product code JPI·February 5, 2010

ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Recall

Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

FDA Recall

Terminated ·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019

ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

FDA Recall

Terminated ·Abbott Laboratories, Inc·Product code CGZ·June 10, 2004

DCI Equipment Track Mount Light Assembly, 110v

FDA Recall

Terminated ·Dental Equipment LLC·Product code EAZ·May 1, 2007

VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

FDA Recall

Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

FDA Recall

Open, Classified ·Envisiontec US Llc·Product code EBZ·January 20, 2022

Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

FDA Recall

Terminated ·Abbott Laboratories, Inc·Product code CGZ·August 28, 2018

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

FDA Recall

Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.

FDA Recall

Terminated ·OPTI Medical Systems, Inc·Product code CGZ·April 20, 2009

Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

FDA Recall

Open, Classified ·Handpiece Headquarters·Product code EBZ·April 4, 2018

Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064

FDA Recall

Terminated ·Abbott Laboratories, Inc·Product code CGZ·September 26, 2007

ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

FDA Recall

Terminated ·Abbott Laboratories, Inc·Product code CGZ·May 23, 2008

bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.

FDA Recall

Terminated ·Ivoclar Vivadent, Inc.·Product code EBZ·April 14, 2014