Z-3017-2018 Class II Terminated
FDA device recall Z-3017-2018 was initiated by Remel Inc on Aug 13, 2018 and is designated Class II. Reason for recall: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. The recall status is terminated (terminated Jun 18, 2019). Affected quantity: 2730 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 19, 2018
- Initiation Date
- Aug 13, 2018
- Termination Date
- Jun 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3017-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026