Recall record at a glance
| Official record | Z-1328-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Opgen Inc. |
| Report date | May 22, 2019 |
| Recall initiation date | Mar 18, 2019 |
| Quantity | 80 slides |
| Location | Gaithersburg, MD, United States |
Official product description
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures
Why the product was recalled
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Distribution information
US Distribution to states of: CT, MI and VA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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