FDA Enforcement
Class II
Terminated
STA UNICALIBRATOR (ref. 00675)
Recall: Z-0737-2020
·
Reported January 1, 2020
Enforcement
- Recall Number
- Z-0737-2020
- Event ID
- 84402
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Diagnostica Stago, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 1, 2020
- Initiation Date
- November 18, 2019
- Classification Date
- December 23, 2019
- Termination Date
- January 12, 2023
- Address
- 5 Century Dr, Parsippany, NJ, 07054-4607, United States
Description
STA UNICALIBRATOR (ref. 00675)
Reason
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Code Info
REF: 00675 Lot Numbers: 253180, 253964, 254721, 255108 UDIs: (01)13607450006756(11)171231(17)191231(10)253180(241)00675 (01)13607450006756(11)180630(17)200630(10)253964(241)00675 (01)13607450006756(11)181130(17)201130(10)254721(241)00675 (01)13607450006756(11)190228(17)210228(10)255108(241)00675
Distribution
US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
Quantity
5,498