CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report
NEL GBS Medium in 100x15mm plate (Standard Petri Dish) recalled
Northeast Laboratory Services is recalling NEL GBS Medium in 100x15mm plate (Standard Petri Dish), distributed nationwide in the US. The recall was initiated on 21 Dec 2015 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-1313-2016
- FDA event ID
- 73325
- Recalling firm
- Northeast Laboratory Services, Winslow, ME
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2015
- FDA classified
- 1 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Dec 2015 | Recall initiated by company | |
| 1 Apr 2016 | Classified by FDA | +102 days |
| 13 Apr 2016 | 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
Product marketed without a 510 (k)
Product as listed by the FDA
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
Product marketed without a 510 (k)
Which lots are affected?
Al lot codes
Where was it sold?
Nationwide Distribution.
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 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.
Other products in this recall event
1 other product · FDA event 73325This product is part of a recall event; the main page for the event is NEL- GBS Medium (Broth Fill mm Screw Cap Tube recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NEL- GBS Medium (Broth Fill mm Screw Cap Tube recalled | Northeast Laboratory Services | Other | Nationwide |
More recalls from Northeast Laboratory Services
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NEL- GBS Medium (Broth Fill mm Screw Cap Tube recalled | Northeast Laboratory Services | Other | Nationwide |
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