[1077106]
We began noticing an increase in the number of negative results with a rubella igg antibody kit. It is called mfr impact rubella latex agglutination kit lot#0627238. We had used the kits for one week when we opened a fresh kit and the positive and weak positive controls were not as reactive as usual. We opened another kit -same lot number- and the controls looked fine. A patient tested on both kits was negative with the first kit and strong positive with the second. It called inverness medical who asked me to send them back the kit. I also sent them the patient's sample mentioned above. Approximately 100ul -2 drops- was put into a small screw top vial, sealed with parafilm, placed into another specimen mailing tube inside a foam rubber insert and packed with gauze and sealed with a screw cap. This container was then placed into an outer box along with the defective kit packaged in its original box. When this kit was received by mfr, they said that the sample had leaked and compromised the kit, so they could not test the kit. That is nonsense - it could not have possibly leaked outside two screw cap containers and compromised a kit which was inside its own box with reagents in their own screw cap vials. Even if somehow it had leaked out, it would have been absorbed by the foam rubber and gauze and could not get out of the second outer tube. It only takes 10ul to do the test and i did not have any more serum on that patient to send them. I could see it getting caught in the cap and they thought it might have leaked but to compromise the kit - no way. I initially thought it was just the one kit that wasn't working - perhaps it was frozen in shipment, although, the other kits received in the same box appeared to be ok. Our external controls worked fine. We continued to see more negative patients than usual. This worried us and i decided to try a competitor's assay -abbott- all positives agreed with the two kits. Which kit was working properly? So i sent some of the discrepant samples to a reference lab. All sera agreed with abbott's results. In the meantime, distributor sent me two kits of a second lot number -0111239-. I also had several conversations with them since dec. 22, when i first reported the problem to distributor. On one conversation, i was told that i was not the only laboratory reporting a problem and that several other labs had reported similar results. Distributor could not understand why it was taking wampole so long to investigate the problem -two months before a report-. I was told that supervisors were involved but not given names. It was not until 2/23/09, that i received a phone call from distributor, now saying that there were only two labs affected - mine and another one and the other lab did not have any of their kit left to send back to them. I asked what happened to the "several labs" that they referred to in previous phone conversation. I was told by the technical rep that i was dealing with -, that she only had two labs. I asked how many labs other technical reps were dealing with and i was told that was proprietary information. There would be no recall notice since not enough labs were affected. She also told me that wampole pulled a kit from their shelf and tested it and it worked fine. But it took them two months to do that? From the difference in information that they gave me at times, i feel that some sort of cover up is going on. They don't know why some kits are not working and even the ones that appear to be working are not at their usual sensitivity. We have switched our rubella igg antibody assay to abbott reagents because i can no longer trust wampole. I have contacted the physicians of all patients affected, modified reports, and sent letters explaining the problem. Along with my lab manager, we feel that this problem needs to be addressed by the fda and not just "swept under the rug". They asked me to send back two kits of lot number 0627238 that we are not using. I tested some sera with them and with lot number 0111239 and abbott and will send the 10 coded serum samples with them for their further evaluation - 2 negative, 1 positive with both kits, 3 positive by abbott and a reference lab and negative with both their lot numbers, and 4 positive with lot number 0111239 and negative with lot number 0627238. Dates of use: two months, 2008 - 2009. Diagnosis: rubella immune status. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5