CLASS III Device recall · Reported 7 Jun 2017 · FDA Enforcement Report
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN recalled
Acumedia Manufacturers is recalling Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081, distributed in Illinois. The recall was initiated on 8 Aug 2016 and the FDA has classified it as Class III.
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-2212-2017
- FDA event ID
- 77281
- Recalling firm
- Acumedia Manufacturers, Lansing, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Aug 2016
- FDA classified
- 1 Jun 2017
- Reported
- 7 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 8 Aug 2016 | Recall initiated by company | |
| 1 Jun 2017 | Classified by FDA | +297 days |
| 7 Jun 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Where it was distributed
US in the state of IL
Questions about this recall
Why was it recalled?
Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
Which lots are affected?
PN 91081C, Lot 108367A PN 91081C, Lot 107632A
Where was it sold?
US in the state of IL
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 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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