FDAClass IIIDecember 2, 2015

Thermo Scientific p21 WF1 Ab-3 recall: Labeling Error

Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor…

Why was Thermo Scientific p21 WF1 Ab-3 recalled?

It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.

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?

Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016.

Product
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor…
Recalling firm
Lab Vision Corporation
Quantity
5 vials
Distribution
Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands.
Recall date
December 2, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
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