Food, drugs, devices › Bio-Rad Laboratories, Inc.
Device recall: The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately
FDA enforcement event 71406 is a device recall by Bio-Rad Laboratories, Inc. of Redmond, WA, initiated 13 May 2015 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 5 Nov 2015. Initiation: voluntary: firm initiated. Bio-Rad Laboratories, Inc. has 20 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bio-Rad Laboratories, Inc., Redmond, WA.
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."
Distribution
"US Distribution to the states of : AZ, CA, ID, MO, and NH."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1840-2015 | 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. | 20 vials | Class III | Terminated | 1 Jul 2015 |
Context
Other enforcement events for Bio-Rad Laboratories, Inc.
All 20 events for Bio-Rad Laboratories, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of : AZ, CA, ID, MO, and NH."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Nov 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.