Recall Z-1194-2019 ยท CJW Bromcresol Purple Dye-Binding, Albumin
Roche Diagnostics Corporation
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.
| Date | Mar 18, 2019 |
| Status | Terminated |
| Reason | The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 774 |
| Distribution | US Nationwide distribution in the states of: GA, IL, KY, MI, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K844426 | ALBUMIN BCP Boehringer Mannheim Corp., Jan 7, 1985 |