FDAClass IIDecember 25, 2013

Streptex* Latex D recall

Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc.…

Why was Streptex* Latex D recalled?

The product may give weak or false negative test results.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot 1149576, exp January 2014

Product
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc.…
Recalling firm
Remel Inc
Quantity
109 kits
Distribution
Nationwide Distribution
Recall date
December 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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