Recall Z-2268-2016— Alere San Diego, Inc.
Class III · Terminated
Class III FDA medical device recall by Alere San Diego, Inc., initiated 2016-06-22, terminated 2018-01-29. It names one FDA 510(k) clearance: K042272. Product: 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: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect..
- Recalling firm
- Alere San Diego, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-06-22
- Terminated
- 2018-01-29
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.