Culture Media, Non-propagating Transport

Cepheid, Sample Collection Device, Part: 900-0370

Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

COVID Test Kit Nonsterile

Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX

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MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Clean Catch Urine Kit NS 178489, AHMU58A

Affected products were assembled off-site by individuals who may not have been properly trained.

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Affected products were assembled off-site by individuals who may not have been properly trained.

remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab

Pouch may be inadequately heat sealed compromising sterility

BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens;

A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.

BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens;

A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.