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Recall Observatory FDA recall evidence

Device product

remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720

Z-3017-2018

August 13, 2018

Class II

Product summary

Firm
Remel Inc
Event
Event 80813
Status
Terminated
Classification
Class II
Quantity
2730 units
Official record key
device-enforcement:Z-3017-2018

Official wording

Reason: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Code information: (a) 10ML, REF 07182, Lot numbers: 258907, 260413, 258908, 260519 (b) 10ML, REF 07180, Lot numbers: 259526, 258906, 258903, 258904, 258905 (c) 5ML, REF 064732, Lot numbers: 271667, 258182, 259521 (d) 5ML, REF 064730, Lot numbers: 254755, 272020, 260509, 258181, 273564, 258627, 271476, 258629, 271665, 259507, 251146, 272499 (e) 9ML, REF 064720, Lot numbers: 254749, 272497, 251145, 272015, 258183, 258626, 271479, 258625

Distribution pattern: US, Canada, Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.