CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report

Variant II beta-thalassemia Short Program recalled

Bio-Rad Laboratories is recalling Variant II beta-thalassemia Short Program, distributed in 10 states. The recall was initiated on 8 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015

Quantity recalled457 kits

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-1537-2014
FDA event ID: 68016
Recalling firm: Bio-Rad Laboratories, Hercules, CA
Classification: Class II
Status: Terminated
Recall initiated: 8 Apr 2014
FDA classified: 2 May 2014
Reported: 14 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

8 Apr 2014	Recall initiated by company
2 May 2014	Classified by FDA	+24 days
14 May 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

There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.

Product as listed by the FDA

Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.

Where it was distributed

Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.

Alabama California Connecticut Georgia Louisiana Massachusetts North Carolina New Jersey New York Washington

Questions about this recall

Why was it recalled?

There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.

Which lots are affected?

Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015

Where was it sold?

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 26 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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