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.
This recall has been terminated (originally issued March 18, 2019).
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- March 18, 2019
- Terminated
- August 28, 2020
- Recall Number
- Z-1194-2019
- Quantity
- 774
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Distribution
US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Lot / Code Info
Catalog Number 05975573190 Lot Number 35651401
Root Cause
Process control
Action Taken
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 Roche10060@stericycle.com 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.