Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of whic

FDA device recall Z-0466-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

A reagent within the test may return false negative results.

Action taken

ThermoFisher sent a Medical Device Recall letter dated October 23, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative results for the affected product. Customers should review their inventory for the affected products and discard them. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed customers should contact those entities, advise them of the situation and provide them with a copy of this letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Root cause

Other

Status

Terminated

Product code

LIB

Quantity affected

59/50 test boxes

Distribution

Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.

Date initiated

2014-10-23

Date posted

2014-12-16

Date terminated

2015-01-22

Location

Lenexa, KS