Z-1840-2015Class III

The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold...

Name: Z-1840-2015 The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold...
Creator: Bio-Rad Laboratories, Inc.
Published: 2015-05-13
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2015-05-13 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories, Inc. began a recall of The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit... on 2015-05-13. FDA classified it as Class III and gives the reason as "The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1840-2015
Classification: Class III
Status: Terminated
Initiated: 2015-05-13
Posted: 2015-06-25
Terminated: 2015-11-05
Recalling firm: Bio-Rad Laboratories Inc.
Product: The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Bio-Rad Laboratories Inc, sent an Urgent Product Correction letter dated May 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalled calibrator is a spare component which is sold separately from the MONOLISA Anti-HBs EIA Kit and the kit is not affected by this recall. Customers were informed that testing was performed and the Anti-HBs 10 mLU/mL Calibrator was acceptable to use through the expiration date of the kit dated 2015-11-30. Customers with questions can call the firm at 1-800-224-6723, option #2, then #3.
Quantity in commerce: 20 vials
Distribution: US Distribution to the states of : AZ, CA, ID, MO, and NH.
Product codes and lots: lot no. 11130382, expiration date 2016-04-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1840-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1840-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25

Product code JJX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)