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