Recall Z-2952-2020 ยท QBD Microbial Nucleic Acid Storage And Stabilization Device
LONGHORN VACCINES AND DIAGNOSTIC
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of inf
| Date | Jun 3, 2020 |
| Status | Open, Classified |
| Reason | The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach. |
| Root cause | Error in labeling |
| Action | URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/1/20 was distributed to the customer. Update on PrimeStore MTM (Molecular Transport Media) and guanidine thiocyanate. We are sending you this letter to notify you that PrimeStore MTM tubes may have been delivered to some users without labels. Users may not be able to identify the tubes as PrimeStore MTM tubes without these labels. If samples stored or transported in PrimeStore MTM tubes are tested on the Hologic Panther or the Hologic Fusion System or come into contact with bleach they can produce cyanide gas. The solution in these |
| Quantity | 1,936,050 |
| Distribution | Nationwide distribution including in the state of MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.