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U.S. Department of Health and Human Services

Class 2 Device Recall Albumin BCP

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 Class 2 Device Recall Albumin BCPsee related information
Date Initiated by FirmMarch 18, 2019
Create DateApril 18, 2019
Recall Status1 Terminated 3 on August 28, 2020
Recall NumberZ-1194-2019
Recall Event ID 82388
510(K)NumberK844426 
Product Classification Bromcresol purple dye-binding, albumin - Product Code CJW
ProductAlbumin 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.
Code Information Catalog Number 05975573190 Lot Number 35651401
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
317-5214343
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionUrgent 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.
Quantity in Commerce774
DistributionUS Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CJW
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