Z-1194-2019Class II

Albumin BCP

Name: Z-1194-2019 Albumin BCP
Creator: Roche Diagnostics Corporation
Published: 2019-03-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-03-18 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corporation began a recall of 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... on 2019-03-18. FDA classified it as Class II and gives the reason as "The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1194-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-18
Posted: 2019-04-18
Terminated: 2020-08-28
Recalling firm: Roche Diagnostics GmbH
Product: 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.
Product code: CJW Bromcresol Purple Dye-Binding, Albumin
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.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 774
Distribution: US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Product codes and lots: Catalog Number 05975573190 Lot Number 35651401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1194-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1194-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-18

Product code CJW

K844426Class IIAlbumin BcpBoehringer Mannheim Corp. / cleared 1985-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)