Lab Vision p21 WF1 Antibody Recalled for Incorrect Concentration Labeling
Lab Vision Corporation is recalling p21 WF1 Ab-3 antibody vials because the label incorrectly states the concentration as 0.2 mg/ml instead of the actual 0.4 mg/ml.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding concentration, with no reported injuries or illnesses.
Plain-English summary
Lab Vision Corporation is recalling Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) antibody vials, product codes MS-230-P and MS-230P0. The recall involves 5 vials with lot numbers 230P1409A and 230P1409C, both with an expiry date of September 2016.
The recall was initiated because the product labeling incorrectly describes the concentration of the antibody. The label reads 0.2 mg/ml, but the actual concentration is 0.4 mg/ml. This product is intended for qualitative immunohistochemistry with formalin-fixed, paraffin-embedded tissue sections.
The affected products were distributed worldwide, including in the United States (California and Washington) and in Serbia, Germany, and the Netherlands. Users of this product should stop using the affected vials and contact Lab Vision Corporation for further instructions.
The recalled product
- 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 suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds…
- Manufacturer
- Lab Vision Corporation
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Product code: MS-230-P
- lot 230P1409A
- Expiry 9-2016
- Product code: MS-230-P0
- lot 230P1409C
- Expiry 9-2016.
Distribution
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