DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the

FDA device recall Z-2884-2016 · posted 2016-09-23 · Terminated

Recall details

Recalling firm

Microgenics Corporation

Reason for recall

Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.

Action taken

The firm, Thermo Fisher Scientific, sent an "URGENT MEDICAL DEVICE FIELD ACTION" letter dated July 25, 2016 by regular mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to determine if they are using or have inventory of any of the affected lots; discontinue use and destroy any remaining inventory of affected lots per local wastes ordinances; retain a copy of the letter for laboratory records; if you have forwarded kits of the affected lots, provide a copy of letter to them; and complete and return attached Medical Device Field Action Response Form within 5 days to Thermo Fisher Scientific Technical Service via fax at 1-888-527-8001 (USA toll free), 510-979-5420 (outside of USA) or email to techservice.mgc@thermofisher.com. If you have any questions contact Technical Services at 1-800-232-3342 (USA only) or 510-969-5000 (outside the USA) press option 2 then option 3.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DKJ

Quantity affected

1708 kits

Distribution

Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.

Date initiated

2016-07-25

Date posted

2016-09-23

Date terminated

2016-11-21

Location

Fremont, CA

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