FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1194-2019
- Recalling firm
- Roche Diagnostics Corporation
- 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.
- Status
- Terminated
- Initiated
- 2019-03-18
- Posted
- not on file
- Terminated
- 2020-08-28
- 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 product in your inventory according to local guidelines. " File this Urgent Medical Device Correction (UMDC) for future reference.
- Quantity
- 774
- Distribution
- US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
- Lot, serial or model codes
- Catalog Number 05975573190 Lot Number 35651401
- 510(k) numbers
- ["K844426"]
- PMA numbers
- not on file
- Product code
- CJW
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28