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.
FDA Recall Z-1194-2019 · Posted None
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Recalling FirmRoche Diagnostics Corporation
Recall StatusTerminated
Product CodeCJW
Date Initiated2019-03-18
Date Terminated2020-08-28
Product Quantity774
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.
Firm 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
[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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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