| Date Initiated by Firm |
November 15, 2019 |
| Create Date |
December 26, 2019 |
| Recall Status1 |
Terminated 3 on July 01, 2020 |
| Recall Number |
Z-0745-2020 |
| Recall Event ID |
84299 |
| 510(K)Number |
K964348
|
| Product Classification |
Radioassay, vitamin b12 - Product Code CDD
|
| Product |
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 |
| Code Information |
Lot Numbers: IZ01893 Exp. 2019-07-31; I801890 Exp. 2019-11-30 |
Recalling Firm/
Manufacturer |
Tosoh Smd Inc
3600 Gantz Rd
Grove City OH 43123-1895
|
Manufacturer Reason
for Recall |
The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle . In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
Tosoh Bioscience issued Urgent Medical Device Correction on 11/15/19, letter states reason for recall, health risk and action to take:
Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 14-days of receiving this notification by FAX, email, or postal mail as indicated on the form. In the event you receive Error Code 2220, discard the affected vial(s). You may pre-screen pretreatment 1 vials on AIA-2000 analyzers prior to reconstituting the vial to help identify vials that may return Error Code 2220. This is an optional pre-screen step and is not required for use of vials from the impacted lots. This is a voluntary customer notification that should be provided to all staff members operating the Tosoh AIA-2000 Analyzer.. Please maintain awareness of this notification by filing it with your laboratory records and forward this information to others who may have received this product. Should you have any questions regarding this medical device notification, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST). |
| Quantity in Commerce |
1012 units |
| Distribution |
Nationwide
Foreign: Columbia, Dominic Republic, Ecuador |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = CDD and Original Applicant = TOSOH MEDICS, INC.
|
