Medical Device Recall: Z-0014-05

FDA Recalls dataset · Firm: Zymed Laboratories Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-04-06 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-05.

Recall Res Number
Z-0014-05
Recalling Firm / Manufacturer
Zymed Laboratories Inc.
FEI Number
3000203719
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-04-06
Date Posted
2004-10-09
Date Terminated
2004-10-29
Product Code
MXZ
Event Number
29984
Product Quantity
24 vials of the mouse anti-TTF-1 concentrate have been released in distribution.
Product Description Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
Reason for Recall Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
Action Details The firm has conducted telephone calls and visits to its consignees, with confirmation done by phone and fax. The firm has recovered or accounted for 100% of the products, either returned or destroyed.
Distribution Pattern The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.
Code Information / Serial Numbers Product Number 18-0221, no 510(k) number, Product Code MXZ, lot code 40280262.

Related Establishments / Registrations

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