A matter of vendor concern is the possibility of a manufacturer/vendor recall. Handling a reagent recall is often a challenging and anxiety-ridden process.21 Communication is a key factor in the appropriate and expeditious resolution of the effects of a product recall. Recalls may involve almost any product: reagents, calibrators, and even computer programs that calculate/report laboratory results. Patient safety may be compromised because of errors in reporting screening or diagnostic medical laboratory test results.
Laboratory management must have a plan already in place for such nonconforming events. The vendor relationship is paramount at this time. Vendors will most likely notify customers with a technical or field service bulletin before the FDA full recall announcement. Quality management plans include documenting the amount of product remaining in stock, when its use was suspended, and how it was destroyed or separated for return to the vendor. The laboratory team investigation (which includes risk management) will begin by notifying staff of the recall and to stop using any leftover reagents. Then trace back, usually by data mining, to determine how to best proceed once the number of patients affected has been determined.
The manufacturer/vendor may assist by reimbursing laboratories for the cost of replacing the adversely affected lots. This may be a big deal, especially if the products under recall are PCR reagents or other high-cost items. It also pays to ask as the cost of mailing letters to providers/patients may also be reimbursed. The manufacturer/vendor will have technical experts that can help by providing technical expertise, especially when a replacement test method must be considered.
In one of the three case presentations provided at the close of this module, a recall scenario will be highlighted. See if you can determine how the vendor/manufacturer was able to assist in the massive recall that took place.
