Quality Complaints, Withdrawals and Recalls

Preserve the distinction between observation and conclusion

“The report names a different lot” is an observable discrepancy. “The material is mislabelled” is a conclusion that needs investigation. Record what you found, where you found it and which records you compared, without treating an untested explanation as established.

If the material is suspect, keep it identifiable and out of laboratory use while the concern is assessed under your organisation's procedures. Handle damage or leakage according to the applicable safety instructions; do not open a compromised container just to obtain a photograph.

What to include

Do not send unnecessary personal information or research-confidential files without first agreeing a suitable route. For transit concerns, see damaged shipment reporting.

Keep the case record together

Retain the original label and report references, correspondence and any corrected documents. If a document is replaced, record which version changed and the explanation provided. Avoid overwriting the evidence that first showed the discrepancy.

Where a concern involves a change between lots, the batch-to-batch comparison guide helps identify the reports and conditions that need to be compared.

Complaints, withdrawals and recalls are different decisions

A complaint raises a concern. An investigation examines its cause and scope. A withdrawal or recall concerns action on affected supply. Receiving a complaint does not itself establish that every container from the lot is affected, and a favourable result from one sample does not automatically close every concern.

Ask for the case reference, the information still needed and any instructions applicable to your affected material. This page does not promise a response deadline or describe an unverified notification system. Applicable returns and consumer rights remain separate from the technical investigation.

Supporting checks