Z-0135-2015Class II

HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators...

Name: Z-0135-2015 HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators...
Creator: Abbott Laboratories
Published: 2014-04-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-04-30 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of 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... on 2014-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0135-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-30
Posted: 2014-10-24
Terminated: 2016-12-28
Recalling firm: Abbott Medical
Product: 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.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Product Correction letters dated April 30, 2014 were sent to all customers. The letters included isntructions for customers to: 1) verify that the lot numbr listed on each calibrator bottle agrees with the lot number printed on the value sheet; 2) If HbA1c Calibrators lot 45063UQ12 has already been utilized in your laboratory, verify the concentrations configured for this calibrator lot match the values in the letter; 3) If these do not match, use the values in the letter when calibrating the HbA1c assay using calibrator lot 45063UQ12; and, 4) follow your laboratory protocol regarding the need for reviewing previously reported patient results if incorrect calibrator values were used.
Quantity in commerce: 183 calibrator kits
Distribution: 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.
Product codes and lots: List Number: 4P52-02; Lot Number: 45063UQ12; Expiration Date: 15 DEC 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0135-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0135-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24

Product code JJX

K130255Class IIHemoglobin A1c, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsAbbott Laboratories / cleared 2014-02-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)