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U.S. Department of Health and Human Services

Class 2 Device Recall ChemMate

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 Class 2 Device Recall ChemMatesee related information
Date Initiated by FirmOctober 07, 2002
Date PostedFebruary 21, 2003
Recall Status1 Terminated 3 on May 03, 2004
Recall NumberZ-0560-03
Recall Event ID 25425
ProductChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.
Code Information Lot numbers: R20061A, R20429A, R21002A, and R21002B.
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85737
For Additional Information ContactSam Rua
520-229-3911
Manufacturer Reason
for Recall		Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.
FDA Determined
Cause 2		Other
ActionCustomers were notified by letter sent on 9/27/2002. Product has been replaced and this recall is complete. No injuries or illness was reported.
Quantity in Commerce60
DistributionNationwide to pathology laboratories and hospitals.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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