CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report
Thioglycollate Medium W/o Indicator recalled by Remel
Remel is recalling remel Thioglycollate Medium W/O Indicator. The recall was initiated on 13 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3018-2018
- FDA event ID
- 80813
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2018
- FDA classified
- 7 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 13 Aug 2018 | Recall initiated by company | |
| 7 Sep 2018 | Classified by FDA | +25 days |
| 19 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Where it was distributed
US, Canada, Singapore
Questions about this recall
Is Thioglycollate Medium W/o Indicator recalled?
Yes. Remel recalled Thioglycollate Medium W/o Indicator on 13 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-3018-2018.
Why was it recalled?
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Which lots are affected?
(a) 9ML, REF 064700, Lot numbers: 254751, 259508, 272498 (b) 10ML, REF 07176, Lot numbers: 259521 (c) 9ML, REF 064702, Lot numbers: 274247
Where was it sold?
US, Canada, Singapore
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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