Recall Z-0465-03 ยท LYR Helicobacter Pylori
Meridian Bioscience Inc
Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
| Date | Jan 23, 2003 (initiated Dec 26, 2002) |
| Status | Terminated |
| Reason | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
| Root cause | Other |
| Action | The firm mailed notices to their affected customers on 12/26/2002. The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps. If properly sealed, the use of the microwells may be continued. Test wells in pouches with defective seals are to be quarantined and destroyed. The customers are asked to report back to the firm. All test microwell plates in defective pouches will be replaced by the firm. |
| Quantity | 1,020 kits |
| Distribution | The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA Meridian Diagnostics, Inc., Dec 17, 1998 |