CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
HbA1c Calibrators LN 4P52-02 consists recalled by Abbott Laboratories
Abbott Laboratories is recalling HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c mL and mL. The recall was initiated on 30 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0135-2015
- FDA event ID
- 68201
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2014
- FDA classified
- 24 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Apr 2014 | Recall initiated by company | |
| 24 Oct 2014 | Classified by FDA | +177 days |
| 5 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
Where it was distributed
Worldwide Distribution in the countries of Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and United Arab Emirates.
Questions about this recall
Is HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c mL and mL recalled?
Yes. Abbott Laboratories recalled HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c mL and mL on 30 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-0135-2015.
Why was it recalled?
HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
Which lots are affected?
List Number: 4P52-02; Lot Number: 45063UQ12; Expiration Date: 15 DEC 2014
Where was it sold?
Worldwide Distribution in the countries of Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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