FDAClass IIAugust 31, 2022

a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit recall

a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT…

Why was a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit recalled?

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN: a. 10815845020130; 00815845020133. b. 10815845020093, 00815845020096

Product
a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT…
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
a. 5 kits b. 12 kits
Distribution
US Nationwide
Recall date
August 31, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls