Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Reported: August 3, 2016 Initiated: June 22, 2016 #Z-2268-2016
Product Description
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Reason for Recall
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- N/A
- Distribution
- US
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.. Recalled by Alere San Diego, Inc.. Units affected: N/A.
Why was this product recalled? ▼
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Low. Recall number: Z-2268-2016.
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