Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Recall
- Recall Number
- Z-1194-2019
- Event Number
- 82388
- Firm
- Roche Diagnostics Corporation
- FEI Number
- 1823260
- Product Code
- CJW
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 18, 2019
- Terminated
- August 28, 2020
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Urgent Medical Device Correction notification letters dated 3/18/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Stop using and discard all Albumin BCP reagent cassettes from lot number 35651401 (catalog number 05975573190) remaining in your inventory according to your local guidelines. Actions Required " Complete all sections of the enclosed fax form and fax it to 1-833-254-2600 or email it to [email protected] even if you are not requesting product replacement. " Discard remaining affected product in your inventory according to local guidelines. " File this Urgent Medical Device Correction (UMDC) for future reference.
US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
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