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

FDA device recall Z-1840-2015 · posted 2015-06-25 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories, Inc.

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.

Action taken

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

JJX

Quantity affected

20 vials

Distribution

US Distribution to the states of : AZ, CA, ID, MO, and NH.

Date initiated

2015-05-13

Date posted

2015-06-25

Date terminated

2015-11-05

Location

Redmond, WA