Z-3017-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2018
- Initiation Date
- August 13, 2018
- Termination Date
- June 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2730 units
Product Description
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
Reason for Recall
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Distribution Pattern
US, Canada, Singapore
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